Depression Agency-Based Collaboration

University of Pittsburgh

Status: Completed

Conditions: Major Depression; Anxiety Disorder

Treatments: Behavioral: Problem-Solving Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01566318

P30MH090333 (U.S. NIH Grant/Contract)

P30MH090333-PRC1

Details and patient eligibility

About

Seniors who receive supportive services face a variety of psychosocial vulnerabilities that put them at risk for depression. One group with very high risk is older adults receiving aging services through Medicaid waiver programs. This 3-year research uses a randomized controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem solving therapy [PST] and Brief Behavioral Therapy for Insomnia [BBTI]) to prevent depression in seniors receiving aging services.

Full description

The research will determine (i) if a course of problem solving therapy (PST) and Brief Behavioral Therapy for Insomnia (BBTI), with boosters, reduces incidence of major depressive episodes over 12 months relative to usual care, and (ii) the extent to which behavioral therapies achieve these effects through enhancement of protective factors, such as greater self-efficacy, better targeting of services to address needs, and greater control over home environments.

Periodic blood draws will be used to assess biosignatures of depression. Guiding our investigations of pharmacogenetics, inflammation, and proteomics are synergistic interactions among the serotonergic system, the HPA axis, systemic inflammation, growth factors such as brain derived neuro-trophic factor (BDNF), psychosocial stressors, and vascular co-morbidity. Genetic variation in vasopressin receptors, potentially involved in both cardiovascular risk and social attachment, is also associated with recurrence of depression. Similarly, genetic variation in inflammation may influence antidepressant response and medical co-morbidity.

Enrollment: 104 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age => 60 years
• Modified Mini Mental State (3MS) Examination =>80
• Receiving aging services or difficulty with 1+ ADL/IADL
• PHQ-9 score > 0 and <= 9 (and question 1 or 2 is >0)

Exclusion criteria

• Major depressive episode or anxiety disorder within 12 mo
• Ever diagnosed with bipolar disorder or schizophrenia
• Drug or alcohol use disorder within the past 12 months
• Currently taking antidepressants
• Currently taking antianxiety med >4x/week for past 4 weeks

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Problem solving therapy (PST)

Experimental group

Description:

6-8 sessions of PST, with booster, delivered over 8 weeks

Treatment:

Behavioral: Problem-Solving Therapy

Usual care

No Intervention group

Description:

Usual agency care, monitored for mental health services